(62 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of the trocar system, with no mention of AI or ML.
No
The device is described as a port of entry for endoscopic instruments, facilitating surgical procedures rather than directly treating a disease or condition.
No
The device is a trocar system used to provide a port of entry for endoscopic instruments. Its function is to facilitate access for surgical tools, not to diagnose medical conditions.
No
The device description clearly outlines physical components such as cannulas, obturators, seals, valves, and stopcocks, indicating it is a hardware device used in surgical procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "to provide a port of entry for endoscopic instruments" in various endoscopic procedures. This describes a surgical tool used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The descriptions of the different trocar types detail their physical characteristics and how they function to create an opening for instruments. This aligns with a surgical device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Unimax Trocar System's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Product codes
GCJ
Device Description
The Auto-locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-locking Trocar is available from 3-15mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The cannula assembly has universal seal and stopcock.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 3-15mm The cannula assembly (10mm and 12mm type) has a universal seal, a valve, and a stpcock. The cannula assembly (5mm type) has a stopcock.
The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Visible Trocar is available from 5-15mm. Visible Trocar allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve, and a stopcock.
The Hasson Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Hasson Trocar is available from 3-15mm. This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.
The Dilating Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoacopic instruments. The Dilating Trocar is available from 3-15mm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock. There is a built-in universal seal.
The Secondary Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Secondary Trocar is available in 2 different lengths: 5mm/7cm and 5mm/10cm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock.
The Thoracic Trocar consists of a blunt-tipped obturator and a threaded cannula. It is designed for instrument stabilization and also protect against foreign materials entering the chest cavity. Once inserted into the chest, the Thoracic Trocar must be turned clockwise until it is securely seated in the tissue. There are four types of Thoracic Trocars: 6mm/7cm, 11mm/7cm, 13mm/7cm, and 15mm/7cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of safety tests were performed to assess the safety and effectiveness of the Unimax Trocar System. The safety tests were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-12, and ISO 11135-1. The performance testing conducted on subject device and predicate device are listed below:
- Obturator Compatibility
- Insertion & Cannula Stability
- Air Leakage
All the test results demonstrate Unimax Trocar System meets the requirements of its pre-defined acceptance criteria and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Page 1. of 5
OCT 1 7 2011
Unimax Medical Systems Inc. 510(k) Notification
Unimax Trocar System
510(k) Summary
- 5.1 Type of Submission: Traditional
- Preparation Date: 5.2 Aug 9, 2011
5.3 Revised Date:
| 5.4 | Submitter: | Unimax Medical Systems Inc. | ||
|---|---|---|---|---|
| Address: | 8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien, Taipei, | |||
| Taiwan | ||||
| Phone: | 886-2-89191698 | |||
| Fax: | 886-2-89191528 | |||
| Contact: | Sophia Chiu | |||
| Establishment Registration Number: 3007791595 |
5.5 Identification of the Device:
| Proprietary/Trade name: | Unimax Trocar System | ||
|---|---|---|---|
| Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, Thoracic Trocar | |||
| Common Name: | Disposable Surgical Trocar/Cannula | ||
| Classification Name: | Laparoscope, General & Plastic Surgery | ||
| Device Classification: | II | ||
| Regulation Number: | 876.1500 | ||
| Panel: | General & Plastic Surgery | ||
| Product Code: | GCJ |
1
K11 2358
Page 2 of 5
Unimax Trocar System
5.6 Identification of the Predicate Device:
| Predicate Device Name: | ENDOPATH Bladeless Trocar, ENDOPATH Blunt Tip Trocar,
ENDOPATH Dilating Tip Trocar | |
|------------------------|---------------------------------------------------------------------------------------|--|
| Manufacturer: | ETHICON ENDO-SURGERY, INC. | |
| Product Code: | GCJ | |
| 510(k) Number: | K032676 | |
| Predicate Device Name: | Shielded Surgical Trocar | |
| Manufacturer: | ETHICON ENDO-SURGERY, INC. | |
| Product Code: | GCJ | |
| 510(k) Number: | K971475 | |
| Predicate Device Name: | ENDOPATH Disposable Thoracic Trocar Sleeve | |
| Manufacturer: | ETHICON ENDO-SURGERY, INC. | |
| Product Code: | GEA/GCJ | |
| 510(k) Number: | K920110 | |
5.7 Intended Use and Indications for Use of the subject device.
The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
5.8 Device Description
The Auto-locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-locking Trocar is available from 3-15mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The cannula assembly has universal seal and stopcock.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 3-15mm The cannula assembly (10mm and 12mm type) has a universal seal, a valve, and a stpcock. The cannula assembly (5mm type) has a stopcock.
2
Page 3 of 5
Unimax Trocar System
The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Visible Trocar is available from 5-15mm. Visible Trocar allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve, and a stopcock.
The Hasson Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Hasson Trocar is available from 3-15mm. This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.
The Dilating Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoacopic instruments. The Dilating Trocar is available from 3-15mm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock. There is a built-in universal seal.
The Secondary Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Secondary Trocar is available in 2 different lengths: 5mm/7cm and 5mm/10cm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock.
The Thoracic Trocar consists of a blunt-tipped obturator and a threaded cannula. It is designed for instrument stabilization and also protect against foreign materials entering the chest cavity. Once inserted into the chest, the Thoracic Trocar must be turned clockwise until it is securely seated in the tissue. There are four types of Thoracic Trocars: 6mm/7cm, 11mm/7cm, 13mm/7cm, and 15mm/7cm.
3
\11 23 58
Page 4 of 5
Unimax Trocar System
5.9 Non-clinical Testing
A series of safety tests were performed to assess the safety and effectiveness of the Unimax Trocar System. The safety tests were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-12, and ISO 11135-1. The performance testing conducted on subject device and predicate device are listed below:
- · Obturator Compatibility
- · Insertion & Cannula Stability
- · Air Leakage
All the test results demonstrate Unimax Trocar System meets the requirements of its pre-defined acceptance criteria and intended uses.
5.10Substantial Equivalence Determination
The Unimax Trocar System submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared ENDOPATH Bladeless Trocar, ENDOPATH Blunt Tip Trocar, ENDOPATH Dilating Tip Trocar (K032676), Shielded Surgical Trocar (K971475), and ENDOPATH Disposable Thoracic Trocar Sleeve (K920110). Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Item | Proposed
Device
(Unimax
Trocar System) | Predicate Device
(ENDOPATH
Bladeless Trocar,
Blunt Tip Trocar,
Dilating Tip
Trocar) | Predicate Device
(Shielded Surgical
Trocar) | Predicate Device
(ENDOPATH
Disposable
Thoracic Trocar
Sleeve) |
|--------|-------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------|
| Models | Auto-locking | | Shielded | |
| | Bladeless | Bladeless | | |
| | Visible | Bladeless (Visible) | | |
| | Hasson | Blunt Tip | | |
| | Dilating | Dilating | | |
| | Secondary | | | |
| | Thoracic | | | Thoracic |
20
4
Page 5 of ⑤
Unimax Trocar System
| Comprised
| Elements | Cannula | Cannula | Cannula | Cannula |
|---|---|---|---|---|
| Tip of Obturator | Tip of Obturator | Tip of Obturator | Tip of Obturator | |
| Dimension | Diameter: | Diameter: | Diameter: | Diameter: |
| 3-15mm | 5-12mm | 3-12mm | 10mm | |
| Length: | Length: | Length: | Length: | |
| 65-150mm | 65-150mm | 65-150mm | 120mm | |
| Sterilization | EO Sterilization | EO Sterilization | EO Sterilization | EO Sterilization |
| Safety | ||||
| standards | ISO 11135-1 | |||
| ISO 10993-1 | ||||
| ISO 10993-5 | ||||
| ISO 10993-7 | ||||
| ISO 10993-10 | ||||
| ISO 10993-12 | ISO 11135-1 | |||
| ISO 10993-1 | ||||
| ISO 10993-5 | ||||
| ISO 10993-7 | ||||
| ISO 10993-10 | ||||
| ISO 10993-12 | ISO 11135-1 | |||
| ISO 10993-1 | ||||
| ISO 10993-5 | ||||
| ISO 10993-7 | ||||
| ISO 10993-10 | ||||
| ISO 10993-12 | ISO 11135-1 | |||
| ISO 10993-1 | ||||
| ISO 10993-5 | ||||
| ISO 10993-7 | ||||
| ISO 10993-10 | ||||
| ISO 10993-12 | ||||
| Performance | ||||
| standards | Not Applicable | Not Applicable | Not Applicable | Not Applicable |
| Performance | ||||
| Testing Item | Obturator | |||
| Compatibility | Obturator | |||
| Compatibility | Obturator | |||
| Compatibility | Obturator | |||
| Compatibility | ||||
| Insertion & | ||||
| Cannula | ||||
| Stability | Insertion & Cannula | |||
| Stability | Insertion & | |||
| Cannula Stability | Insertion & Cannula | |||
| Stability | ||||
| Air Leakage | Air Leakage | Air Leakage | Air Leakage |
5.11 Conclusion
After analyzing bench tests, safety testing data, it can be concluded tha: Unimax Trocar System is as safe and effective as the predicate device.
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Unimax Medical Systems, Inc. % AcmeBiotechs Co., Ltd. Mr. Michael Lee No. 45, Minsheng Road Danshui Town, Taipei County Taiwan, China 251
FEB 1 0 2012
Re: K112358
Trade/Device Name: Unimax Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 11, 2011 Received: August 16, 2011
Dear Mr. Lee:
This is a corrected SE letter which was dated October 17, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 - Mr. Michael Lee
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
cerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K 1123 58
Unimax Trocar System
Indications for Use
510(k) Number (if known):
Unimax Trocar System
Devicc Name:
Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, Thoracic Trocar
Indications for Use:
The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
: :
:
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nel RPOgden for mkn
Division of Surgical, Orthopedic, and Restorative Devices
. :
Page 1 of 1
510(k) Number K112358
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